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NCT00000658 · ClinicalTrials.gov registry record · Phase 3
A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma
A Phase 3 study of HIV Infections and Lymphoma, Non-Hodgkin, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT00000658 is a Phase 3 study of HIV Infections and Lymphoma, Non-Hodgkin that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 250 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT00000658, a Phase 3 study of HIV Infections and Lymphoma, Non-Hodgkin, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Allopurinol
- DRUG Doxorubicin hydrochloride
- DRUG Bleomycin sulfate
- DRUG Vincristine sulfate
Study Locations (20)
New York
- SUNY - Buffalo, Erie County Medical Ctr. - Buffalo
- Beth Israel Med. Ctr. (Mt. Sinai) - New York
- NY Univ. HIV/AIDS CRS - New York
- Memorial Sloan-Kettering Cancer Ctr. - New York
- Univ. of Rochester ACTG CRS - Rochester
California
- USC CRS - Los Angeles
- UCLA CARE Center CRS - Los Angeles
- Ucsf Aids Crs - San Francisco
Massachusetts
- Beth Israel Deaconess Med. Ctr., ACTG CRS - Boston
- Beth Israel Deaconess - East Campus A0102 CRS - Boston
- Bmc Actg Crs - Boston
Illinois
- Northwestern University CRS - Chicago
- Rush Univ. Med. Ctr. ACTG CRS - Chicago
Ohio
- Case CRS - Cleveland
- The Ohio State Univ. AIDS CRS - Columbus
Colorado
- University of Colorado Hospital CRS - Aurora
Indiana
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis
Maryland
- Johns Hopkins Adult AIDS CRS - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Est. Completion | 1996-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000658
The ClinicalTrials.gov registry entry for NCT00000658 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (44% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00000658 reports 20 study locations spanning 10 distinct geographic areas - top geographies include New York, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00000658 about?
NCT00000658 is a clinical study titled "A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma". To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence ...
What is the current status of trial NCT00000658?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. Estimated completion is 1996-02.
What conditions does trial NCT00000658 study?
This clinical trial studies the following conditions: HIV Infections, Lymphoma, Non-Hodgkin.
What interventions are being tested in trial NCT00000658?
The interventions under investigation include: Cyclophosphamide (DRUG), Allopurinol (DRUG), Doxorubicin hydrochloride (DRUG), Bleomycin sulfate (DRUG), Vincristine sulfate (DRUG).
Who is sponsoring clinical trial NCT00000658?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00000658 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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